BacT/ALERT

GUDID 03573026428853

Designed for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested/decontaminated clinical specimens.

BIOMERIEUX , INC.

Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD
Primary Device ID03573026428853
NIH Device Record Key465cd786-3db0-4d5c-b479-764d1ac37091
Commercial Distribution StatusIn Commercial Distribution
Brand NameBacT/ALERT
Version Model Number414997
Company DUNS086785110
Company NameBIOMERIEUX , INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026428853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDBSystem, blood culturing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-06
Device Publish Date2020-06-26

On-Brand Devices [BacT/ALERT]

03573026428853Designed for recovery and detection of mycobacteria from sterile body specimens other than blood
03573026629649R3.1 SW/FW for BACT/ALERT VIRTUO

Trademark Results [BacT/ALERT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BACT/ALERT
BACT/ALERT
77523447 3962173 Live/Registered
bioMérieux, Inc.
2008-07-16
BACT/ALERT
BACT/ALERT
75022103 2017525 Live/Registered
BIOMERIEUX, INC.
1995-11-20

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